Senior Quality Assurance Specialist
RK3939
Contract - 12 months
Cork
We're currently recruiting for an exciting opportunity with an award-winning Pharmaceutical organization based in Cork. This is an excellent position for anyone who is looking to join a leading multinational who are one of the best at what they do.
Duties:
* Batch Record Review and material release (including CoA) to ensure compliance with GMP requirements.
* Quality review and approval of Master Batch Record (MBR) record for routine cleaning and process activities, including Automation recipe updates.
* QA Review and Approval of SOPs, Work Instructions and forms from other departments.
* Attendance at Daily/Weekly Operations led Team Meetings.
* Responsible for Gemba Walkdowns & Inspection Readiness Walkdowns from a QA perspective.
* QA review and approval of Warehouse Shipping Picklist.
* Primary QA point of contact for Quarantine Shipments.
* Responsible for Batch Book Filing & Archival.
* QA review and approval of quality non-conformance (NC) records and customer complaint non-conformance records.
* Initiation and ownership of QA non-conformance records.
* Responsible for periodic review of Quality Assurance and Quality Systems SOPs.
* Primary Quality point of contact for attendance at Root Cause Analysis meetings.
* Primary QA point of contact for the Returns process.
Experience and Education:
* Third level Degree in a science or pharmaceutical discipline.
* A minimum of 3 years of experience within the Pharmaceutical Industry.
* Experience in sterile API manufacturing and aseptic processing
* Experience with batch review and HPRA audits
* A working knowledge of quality processes and systems is desirable.
If interested in this posting please feel free to contact Rachel Kent on or for further information.